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| ID | Type | Description | Link |
|---|---|---|---|
| PIC-142-25 | Other Identifier | Hospital Sant Joan de Déu |
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In this study, the investigators will evaluate the dynamics of betaine excretion into breast milk following supplementation. Milk betaine concentrations will be measured at baseline (0 hours) and at 3, 6, and 12 hours after the first dose of 400 milligrams (mg) betaine to assess the short-term impact of maternal betaine supplementation on milk betaine concentration and related metabolites during 12 hours after intake. These measurements will be repeated after one week of daily supplementation with this low dose. Subsequently, the same protocol will be conducted using a higher dose (1.5 gram/day) for one additional week to compare milk betaine concentration and related metabolites before and after the supplementation period at two different doses. Depending on the outcomes, the investigators will also analyze milk macronutrient composition and explore untargeted metabolomic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betaine Supplementation (Sequential Low and High Dose) | Experimental | Participants will receive oral betaine supplementation at a low dose (400 milligrams/day) for one week, followed by a high dose (1.5 grams/day) for one additional week. Milk samples will be collected at baseline and at multiple time points to evaluate betaine dynamics, accumulation, and associated metabolic changes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betaine supplement | Dietary Supplement | Oral betaine supplementation will be administered to lactating women. Participants will receive a dose of 400 milligrams/day for 1 week, followed by 1.5 grams/day for an additional week. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events, focusing on gastrointestinal symptoms. | Baseline, 1 week, 2 weeks |
| Change in betaine concentration in human milk | Variation in betaine levels in breast milk measured at baseline (0 hours) and at 3 hours, 6 hours, and 12 hours after taking supplement | Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the one-carbon metabolite profile of breast milk | Milk samples will be analyzed by liquid chromatography-mass spectrometry to quantify betaine-related metabolites, including dimethylglycine, methionine, S-adenosylmethionine, S-adenosylhomocysteine, cystathionine, choline, homocysteine, methyl folate, and folic acid at the different time-points. | Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Deu | Barcelona | Barcelona | 08950 | Spain |
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This is an interventional nutritional study using a within-subject design, in which lactating women receive sequential low-dose (400 milligrams/day) and high-dose (1.5 grams/day) oral betaine supplementation to assess its dynamics in breast milk.
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